News | Radiology Business | May 22, 2024

Medtronic has reported preliminary findings of the first and only head-to-head trial comparing standard-of-care CT-guided biopsy with electromagnetic navigation bronchoscopy (ENB) for the diagnosis of lung nodules. The data, presented at the American Thoracic Society International Conference, ATS 2024, demonstrated non-inferiority and fewer complications when using ENB, the company reported.

Medtronic has reported preliminary findings of the first and only head-to-head trial comparing standard-of-care CT-guided biopsy with electromagnetic navigation bronchoscopy (ENB) for the diagnosis of lung nodules.

Medtronic has reported preliminary findings of the first and only head-to-head trial comparing standard-of-care CT-guided biopsy with electromagnetic navigation bronchoscopy (ENB) for the diagnosis of lung nodules. The data, presented at the American Thoracic Society International Conference, ATS 2024, demonstrated non-inferiority and fewer complications when using ENB, the company reported. Image courtesy: Medtronic


May 22, 2024 — Medtronic has announced new preliminary data from the VERITAS clinical study using its ILLUMISITE fluoroscopic navigation platform for the electromagnetic navigational bronchoscopy (ENB) procedure to diagnose lung nodules (growth in the lung). Clinical researchers at Vanderbilt University Medical Center who conducted VERITAS as an investigator-initiated study with funding from Medtronic, presented the preliminary results at the American Thoracic Society International Conference, ATS 2024, held May 17-22 in San Diego, CA. Highlights from the written statement issued by the Minneapolis, MN-based company follow.

The data demonstrated that the ENB platform with digital tomosynthesis that was used in the study is the first and only system clinically proven to be non-inferior to CT-guided biopsy – the current standard of care in lung biopsy. The non-inferiority finding indicates that the rates of lung disease diagnosis based on biopsy findings were similar for ENB and CT-guided biopsy. The findings also show the platform significantly reduces the rate of procedure-related complications, which are a key limitation of CT-guided biopsy.

About the VERITAS study

In the study, patients with peripheral lung nodules 10-30 mm with pre-test probability of malignancy ≥10% were randomized 1:1 to ENB or CT-guided biopsy following central review by an independent panel confirming that both procedures were appropriate for the patient and the target nodules. The primary endpoint was navigation diagnostic accuracy through 12 months of follow-up (data for which are anticipated in summer 2024); secondary endpoints included diagnostic yield and safety. Diagnostic yield was strictly defined as the combination of the primary endpoint (diagnostic accuracy) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies. This definition was consistent with the 2024 consensus statement from the American Thoracic Society Assembly on Thoracic Oncology and the American College of Chest Physicians. All non-malignant biopsies were reviewed centrally with diagnostic adjudication by a panel of lung nodule experts blinded to biopsy technique. Of the 258 patients randomized at seven U.S. sites, 234 underwent biopsy procedures.

Key findings reported by Medtronic include:

- For the secondary endpoint of diagnostic yield, ENB was diagnostic in 92 of 121 patients (76%) while CT-guided biopsy was diagnostic in 86 of 113 (76%). The probability that ENB was noninferior to CT—guided biopsy is 97%, exceeding the noninferiority threshold.

- Complications occurred in significantly fewer ENB procedures (5.8%, n=7) compared with CT-guided biopsy procedures (31%, n=35) (p<0.001).

- These included pneumothoraces requiring tube thoracostomy (0.8%, n=1 for ENB vs. 8.8%, n=10 for CT-guided), and pneumothoraces not requiring thoracostomy (2.5%, n=3 for ENB vs. 19.5%, n=22 for CT-guided), and hemorrhage (0% for ENB vs. 2.7%, n=3 for CT-guided).

- These findings, plus additional advantages of the ENB platform including the ability to simultaneously perform mediastinal staging in the same procedure,6,7 support ENB as preferred approach over CT-guided biopsy for the diagnosis of indeterminate pulmonary nodules when both approaches are reasonable options.

 

“These findings suggest that ENB should be the preferred option over CT-guided biopsy for diagnosing indeterminate pulmonary nodules when both approaches are options,” said Fabien Maldonado, MD, MSc, Overall Principal Investigator at Vanderbilt-Ingram Cancer Center at Vanderbilt University Medical Center (VUMC). “ENB enables providers to biopsy and stage multiple lung nodules within a single procedure. This means one episode of care for patients versus a possible two episodes of care with CT-guided biopsy, potentially reducing delays in patient care and treatment.”

In CT-guided biopsy, a needle is directed through the chest wall under conscious sedation to obtain tissue from suspicious areas. ENB involves guiding a bronchoscope through the throat and into the lungs for tissue sampling while under general anesthesia. Until VERITAS demonstrated the platform’s non-inferiority, diagnostic yield has generally been estimated to be higher with CT-guided biopsy because its use of real-time CT imaging enables accurate navigation to the target nodule.

The ENB platform incorporates intra-procedure digital tomosynthesis (a type of fluoroscopic imaging) that allows the bronchoscopy path to the nodule to be adjusted in real time1,† and enables accurate navigation to the target site.1,2,3, †,‡ It also offers potential advantages by circumventing complications associated with chest wall puncture, such as pneumothorax and pain.4

Due to the absence of head-to-head comparative data with bronchoscopy approaches, CT-guided biopsy has remained the standard of care despite its 25% complication rate.5 VERITAS is the first multicenter, non-inferiority randomized controlled trial to provide a direct comparison of CT-guided biopsy and ENB for diagnosing indeterminate pulmonary nodules.

“Medtronic Surgical is committed to providing clinicians with robust clinical data that allow them to make informed treatment decisions,” said Matt Anderson, senior vice president and general manager, Advanced Surgical Technologies within the Surgical business, which is part of the Medical Surgical Portfolio at Medtronic. “The findings clearly demonstrate that higher complication rates of CT-guided biopsy should no longer be considered a necessary trade-off for diagnostic yield. The reductions in episodes of care and complications with our platform may also reduce the costs of accurate and timely early-stage lung cancer diagnosis.”

The ILLUMISITE platform is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Lung Cancer: Early Detection and Diagnosis in the Spotlight

Lung cancer is the number-one cause of cancer-related death in the United States.8 At the same time, patients have a 92% chance of survival when lung cancer is diagnosed at an early stage and resected immediately.9 The company statement further noted statistics that early detection and diagnosis can improve survival rates of patients with lung cancer before symptoms arise. Healthcare technology innovations help clinicians to effectively and safely sample lung nodule tissue to determine if it’s cancerous and whether the cancer has spread to the lymph nodes. ENB procedures result in significantly fewer patient complications as compared to CT-guided biopsy without compromising cancer detection rates.10

References:

† Based on evidence from a single-center prospective study including a total of 82 consecutive patients

‡ Based on evidence from a single-center retrospective study including a total of 72 consecutive patients

1 Avasarala SK, Roller L, Katsis J, et al. Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-time Target Acquisition. Respiration. Published online September 03, 2021. doi: 10.1159/000518009.

2 Pritchett MA, Bhadra K, Mattingley JS. Electromagnetic Navigation Bronchoscopy With Tomosynthesis-based Visualization and Positional Correction: Three-dimensional Accuracy as Confirmed by Cone-Beam Computed Tomography. J Bronchology Interv Pulmonol. 2021;28(1):10-20. doi:10.1097/LBR.0000000000000687.

3 Dunn BK, Blaj M, Stahl J, Speicher J, Anciano C, Hudson S, Kragel EA, Bowling MR. Evaluation of electromagnetic navigational bronchoscopy using tomosynthesis-assisted visualization, intraprocedural positional correction and continuous guidance for evaluation of peripheral pulmonary nodules. J Bronchology Interv Pulmonol. 2022.

4 Ashraf, Syed Faaz, and Kelvin K W Lau. Navigation bronchoscopy: A new tool for pulmonary infections. Medical mycology vol. 57,Supplement_3 (2019): S287-S293. doi:10.1093/mmy/myz058.

5 Vachani A, Zhou M, Ghosh S, Zhang S, Szapary P, Gaurav D, Kalsekar I. Complications After Transthoracic Needle Biopsy of Pulmonary Nodules: A Population-Level Retrospective Cohort Analysis. J Am Coll Radiol. 2022 Oct;19(10):1121-1129. doi: 10.1016/j.jacr.2022.04.010. Epub 2022 Jun 20. PMID: 35738412.

6 Folch, E. E., Labarca, G., Ospina-Delgado, D., Kheir, F., Majid, A., Khandhar, S. J., ... & Fernandez-Bussy, S. (2020). Sensitivity and safety of electromagnetic navigation bronchoscopy for lung cancer diagnosis: systematic review and meta-analysis. Chest, 158(4), 1753-1769. REF-23707

7 Folch, E. E., Pritchett, M. A., & Nead, M. A. (2018). Brief Title: Electromagnetic Navigation Bronchoscopy for Lung Lesions Title: Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. REF-12955

8 Siegel, RL, Miller, KD, Fuchs, HE, Jemal, A. Cancer statistics, 2022. CA Cancer J Clin. 2022. https://doi.org/10.3322/caac.21708.

9 International Early Lung Cancer Action Program Investigators; Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006 Oct 26;355(17):1763-71. doi: 1056/NEJMoa060476. Erratum in: N Engl J Med. 2008 Apr 24;358(17):1875. Erratum in: N Engl J Med. 2008 Aug 21;359(8):877. Erratum in: N Engl J Med. 2008 Apr 24;358(17):1862. PMID: 17065637.

10 Lentz R. Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: initial results from the VERITAS multicenter randomized trial. AJRCCM. Published online May 1, 2024. https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2024.209…

More information: www.medtronic.com


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